MAUDE Adverse Event Report: COVIDIEIN 12CC SALINE SYRINGE (10CC); SYRINGE, IRRIGATING (NON DENTAL)

Model Number 8881570121

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2018

Event Type  malfunction  

Event Description

The customer states they identified a piece of hair within the saline solution on a pre-filled flush syringe.

Manufacturer Narrative

A review of the device history record (dhr) for lot no.18b0364 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.No abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer.Review of incoming inspection reports for the syringes used in this batch indicated no nonconformance and was released.Manufacturing records were also reviewed with no issues noted.Cleaning procedure logs indicated all steps were following before and during the filling of this lot.A raw materials investigation also identified no nonconformance.Equipment was in proper functioning condition during the manufacturing, filling and packaging of the lot.However, it was noted the batch showed a higher rate of rejects (discards) for plunger issues during production of this lot.Per the batch report, a reject rate of 2% was noted for this lot, which is slightly higher than usual.Generally, the rate observed is a reject rate of 0.5% to 1%.The reject rate of 2% is below the alert limit of 3%.The syringes rejected by the report are then inspected by certified operators and any defective syringe is discarded.As the hair of the returned sample is located behind the piston, no direct correlation was found between the reject rate and the reported issue of this complaint.All tests performed on the finished product were within acceptable limits at release.One (1) sample was received for evaluation.Inspection of the sample was conducted by the prefill department manager.A long dark hair (or thread) is present inside the plastic flow wrap of the syringe.The hair is attached to the black piston (barely stuck between the piston and the barrel) it is located behind the piston on the side of the plunger.There is no sign of the hair inside the fluid pathway or in the ribs of the piston.The reported issue is confirmed.The exact root cause for the presence of the hair could not be identified.Considering procedures in place for the operators, the controlled environment of operations and cleaning processes, it is very unlikely that a hair could get stuck to the syringe during filling of the syringe.Another probability could be that the syringe was received from the suppler with the hair already stuck to the syringe.The reported customer complaint is confirmed.A root cause could not be determined.The most likely probable cause is hair originated from supplier site.A supplier notification has been sent to inform of the possibility that the hair could have already been inside a bag of components coming from their site.This complaint will be utilized for tracking and trending purposes.

• Brand Name: 12CC SALINE SYRINGE (10CC)
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): COVIDIEIN; 15 hampshire st.; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7790287
• MDR Text Key: 117461962
• Report Number: 1282497-2018-08019
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881570121
• Device Catalogue Number: 8881570121
• Device Lot Number: 18B0364
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1